BENEFITS, OUTCOMES AND LIMITATIONS OF ACTIVE SURVEILLANCE FOR PROSTATE CANCER

Panel discusses long-term effect on quality of life

Orlando, FL, May 17, 2014 — A series of studies evaluating the outcomes, benefits, concerns and quality of life of men undergoing active surveillance for prostate cancer will be presented to media at a special press conference during the 2014 Annual Scientific Meeting of the American Urological Association (AUA). Stacy Loeb, MD, assistant professor at New York University, New York, NY, will moderate the session, which will take place on Saturday, May 17, 2014 at 10 a.m. ET, in the Orange County Convention Center, Orlando, FL.

In recent years, the concept of active surveillance, has become a more viable option for men with low-risk prostate cancer who decide not to undergo active treatment right away. During active surveillance, prostate cancer is carefully monitored for signs of progression through regular PSAs (blood tests for prostate-specific antigen), prostate exams, imaging and sometimes repeat biopsies. If symptoms develop, or if tests indicate the cancer is more aggressive, active treatment might be warranted.

Study Details

Long Term Follow-Up of Large Active Surveillance Cohort (#PD14-03): Although acceptance of active surveillance as a treatment option for prostate cancer has been increasing, data from long-term follow-up of active surveillance in men with favorable or intermediate-risk prostate cancer has been limited. Researchers from Sunnybrook Health Sciences Centre in Toronto, Canada used a prospective single-group cohort study of men enrolled with favorable or intermediate risk prostate cancer who selected active surveillance. Intervention was offered to patients with a PSA doubling time of fewer than three years, Gleason score progression (to 4 + 3 or greater), or unequivocal evidence of clinical progression.

Results showed:

Of the 840 men enrolled, 693 are still alive (censored rate 82.5 percent).

At five, 10, 15, and 20 years after diagnosis, 77.1 percent, 63.4 percent, 52.3 percent, and 52.3 percent of patients, respectively, remained on the active surveillance protocol.

During the follow-up period, 15 died from prostate cancer and seven developed metastatic disease.

In this cohort, the likelihood of dying of other causes was 9.7 times greater than the likelihood of dying from prostate cancer. Investigators concluded active surveillance for favorable risk prostate cancer is feasible and appears safe in the 15-20 year time frame.

Health-Related Quality of Life in Men Undergoing Active Surveillance vs. Radical Prostatectomy for Low Risk Prostate Cancer: A Prospective Multi-Institutional Study (#MP58-20): In men with low-risk prostate cancer, researchers set out to determine if active surveillance would result in better health-related quality of life outcomes than more aggressive therapies such as surgery. As part of this study, researchers from Virginia Mason Medical Center in Seattle, WA and the Center for Prostate Disease Research in Rockville, MD, examined the results of 278 men from eight institutions who were enrolled in the Center for Prostate Disease Research national database between January 2007 and December 2011. Baseline, one- and two-year interval follow-up data on health related-quality of life was collected from men who selected either active surveillance (103) or radical prostatectomy (175). Results showed:

At two years after diagnosis of prostate cancer, sexual function declined for both groups, but larger declines were seen in the radical prostatectomy group (-25.4, 95 percent CI: -30.3, -20.5) vs. the active surveillance group [-7.5, 95 percent CI: -12.8, -2.2(p<0.001)].

At two years, urinary function declined for both groups, however larger declines were also seen in the radical prostatectomy group (-14.0, 95 percent CI: -17.5, -10.6) vs. the active surveillance group [-4.6, 95 percent CI: -9.1, -0.1 (p<0.001)].

No statistically significant differences were found for bowel function, physical health or mental health between the two groups.

Thirteen Years of Experience in Active Surveillance for Prostate Cancer: Malcompliance is a Major Concern in the Long-Term (#MP45-02): Long-term follow up of men with prostate cancer shows active surveillance, as a treatment option, may not be as safe as thought, due to men not following up with their physician. Researchers from Cantonal Hospital in Baden, Switzerland conducted a prospective study starting in 1999 at their non-academic institution. The study followed 157 patients on active surveillance over a 13-year period. Results showed after the 13 years:

Twenty-eight percent of all patients required definitive treatment. Almost all of these men were cured from cancer.

Loss to follow-up is considerable: 27 percent of all patients did not show up to the recommended appointments.

Only 50 percent remained in the active surveillance group, 11 percent were lost to follow up and the overall drop-out rate was 36 percent.

Does Active Surveillance Miss the Window for Cure? Matched Comparison of Immediate vs. Delayed Prostatectomy in a Nationwide Population-Based Cohort (#MP62-06): Active surveillance prior to radical prostatectomy is a viable strategy to reduce the chances of overtreatment while ensuring the window of opportunity for cure is not missed, according to a new study by researchers from New York University and the National Prostate Cancer Register of Sweden. They compared 634 men who had delayed prostatectomy after surveillance to 634 matched patients who had immediate radical prostatectomy. These data show, although men who underwent delayed radical prostatectomy had more high-grade disease compared to those who had immediate radical prostatectomy, there were no significant differences in prostate cancer recurrence or death. Specific results showed:

The 634 men identified from the National Prostate Cancer Register of Sweden who underwent a radical prostatectomy after a period of active surveillance were more likely to have higher grade disease at the time of surgery.

On multivariable analysis controlling for other factors, delayed radical prostatectomy was associated with a greater risk of an increased Gleason score (above seven) at time of surgery.

There were no significant differences in biochemical recurrence, secondary treatment, or prostate cancer death between the two groups at a median follow-up of 7 years.

“Not all prostate cancers require immediate radical treatment, which makes active surveillance a very viable option for some men,” said Dr. Loeb. “These data suggest active surveillance with selective delayed therapy, such as radical prostatectomy, is a viable strategy for reducing the risk of overtreatment and is an important consideration for physicians to discuss with their patients.”

NOTE TO REPORTERS: Experts are available to discuss this study outside normal briefing times. To arrange an interview with an expert, please contact the AUA Communications Office at 410-689-3932or e-mail cfrey@AUAnet.org.

About the American Urological Association: The 109th Annual Meeting of the American Urological Association takes place May 16 – 21 at the Orange County Convention Center in Orlando, FL.

Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is a leading advocate for the specialty of urology, and has more than 20,000 members throughout the world. The AUA is a premier urologic association, providing invaluable support to the urologic community as it pursues its mission of fostering the highest standards of urologic care through education, research and the formulation of health policy.